MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT I2000SR; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	03M74-01
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed white smoke coming out from the back of the instrument near the pump storage area.The customer turned off the power and unplugged the instrument.The fse replaced the vacuum pump.There is no further smoke or smell coming from the instrument.Fse performed a vacuum system test which passed and controls in range.No impact to patient management was reported.
Event or Problem Description
The customer observed white smoke coming out from the back of the instrument near the pump storage area.The customer turned off the power and unplugged the instrument.The fse replaced the vacuum pump.There is no further smoke or smell coming from the instrument.Fse performed a vacuum system test which passed and controls in range.No impact to patient management was reported.
Additional Manufacturer Narrative
Service was dispatched due to the customer reporting smoke coming from the back architect i2000sr, serial # (b)(6).Service determined the pump, vacuum (rohs) (7-77795-02) the likely cause and replaced the part, resolving the smoke issue.No fire or injury to personnel reported.The instrument service history review revealed no additional tickets associated with smoke.There were no additional service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.The 2025 ul certification memo indicates that abbott diagnostic equipment and accessories are certified to the appropriate safety standards, and adequate protection is provided for the operator against spread of fire from the equipment.The damaged components were limited to the pump, vacuum (rohs) (7-77795-02) and the smoke did not spread to other parts of the instrument.A review of tracking and trending for the did not identify any increased complaint activity for the complaint issue.Review of the manufacturing documentation did not identify any non-conformances associated with the complaint issue.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency was identified.

• Brand Name: ARCHITECT I2000SR
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 22521031
• Report Number: 3016438761-2025-00408
• Device Sequence Number: 15456795
• Product Code: JJE
• UDI-Device Identifier: 00380740023386
• UDI-Public: (01)00380740023386
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03M74-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown